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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY UNKNOWN VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC NEUROSURGERY UNKNOWN VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number UNKNOWN-V
Device Problems Complete Blockage (1094); Fracture (1260); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 04/30/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Aaron m. Yengo-kahn, john c. Wellons iii, todd c. Hankinson, jason s. Hauptman, eric m. Jackson, hailey jensen, mark d. Krieger, abhaya v. Kulkarni, david. D. Limbrick jr. , patrick j. Mcdonald, robert p. Naftel, jonathan a. Pindrik, ian f. Pollack, ron reeder, jay riva-cambrin, curtis j. Rozzelle, mandeep s. Tamber, william e. Whitehead, and john r. W. Kestle. Treatment strategies for hydrocephalus related to dandy-walker syndrome: evaluating procedure selection and success within the hydrocephalus clinical research network. Journal of neurosurgery pediatrics 28 (2021). Doi: 10. 3171/2020. 11. Peds20806. Objective treating dandy-walker syndrome¿related hydrocephalus (dwsh) involves either a csf shunt-based or endoscopic third ventriculostomy (etv)¿based procedure. However, comparative investigations are lacking. This study aimed to compare shunt-based and etv-based treatment strategies utilizing archival data from the hydrocephalus clinical research network (hcrn) registry. Methods a retrospective review of prospectively collected and maintained data on children with dwsh, available from the hcrn registry (14 sites, 2008¿2018), was performed. The primary outcome was revision-free survival of the initial surgical intervention. The primary exposure was either shunt-based (i. E. , cystoperitoneal shunt [cps], ventriculoperitoneal shunt [vps], and/or dual-compartment) or etv-based (i. E. , etv alone or with choroid plexus cauterization [cpc]) initial surgical treatment. Primary analysis included multivariable cox proportional hazards models. Results of 8400 hcrn patients, 151 (1. 8%) had dwsh. Among these, the 102 patients who underwent shunt placement (79 vpss, 16 cpss, 3 other, and 4 multiple proximal catheter) were younger (6. 6 vs 18. 8 months, p <(><<)> 0. 001) and more frequently had 1 or more comorbidities (37. 3% vs 14. 3%, p
=
0. 005) than the 49 etv-treated children (28 etvcpc). Fifty percent of the shunt-based and 51% of the etv-based treatments failed. Notably, 100% (4/4) of the dual compartment shunts failed. Adjusting for age, ba seline ventricular size, and comorbidities, etv-based treatment was not significantly associated with earlier failure compared with shunt-based treatment (hr for failure 1. 32, 95% ci 0. 77¿2. 26; p
=
0. 321). Complication rates were low: 4. 9% and 6. 1% (p
=
0. 715) for shunt- and etv-based procedures, respectively. There was no difference in survival between etv-cpc¿ and etv-based treatment when adjusting for age (hr for failure 0. 86, 95% ci 0. 29¿2. 55, p
=
0. 783). Reported events. - the overall failure rate was 50%. Notably, 100% of initial complex shunts failed. Of the shunt-based failures the causes are as follows: obstruction (41%), infection (16%), fracture (10%), over/underdrainage (functional) (8%), misplacement (2%), additional proximal catheter required (12%), and other (12%). About 80% of failures resulted in a simple shunt revision (i. E. , replacement/revision of the single catheter system). Only 1 shunt was converted to an etv.
 
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Brand NameUNKNOWN VALVE/SHUNT
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
5290 california ave
irvine CA 92617
Manufacturer (Section G)
MEDTRONIC NEUROSURGERY
5290 california ave
irvine CA 92617
Manufacturer Contact
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12392318
MDR Text Key268943860
Report Number2021898-2021-00156
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 08/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN-V
Device Catalogue NumberUNKNOWN-V
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/31/2021 Patient Sequence Number: 1
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